Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2183-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.

Product Classification:

Class II

Date Initiated: May 11, 2018

Date Posted: June 20, 2018

Recall Number: Z-2183-2018

Event ID: 80172

Reason for Recall:

The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.

Status: Terminated

Product Quantity: 169

Code Information:

UDI: (01)00880304673885(17)230222(10)120150, Lot Number: 120150; UDI: (01)00880304673885(17)201203(10)140700, Lot Number: 140700; UDI: (01)00880304673885(17)211125(10)173480, Lot Number: 173480; UDI: (01)00880304673885(17)210520(10)205730, Lot Number: 205730; UDI: (01)00880304673885(17)210822(10)294370, Lot Number: 294370; UDI: (01)00880304673885(17)210310(10)338750, Lot Number: 338750; UDI: (01)00880304673885(17)210902(10)421970, Lot Number: 421970; UDI: (01)00880304673885(17)210916(10)516680, Lot Number: 516680; UDI: (01)00880304673885(17)210411(10)678370, Lot Number: 678370; UDI: (01)00880304673885(17)220603(10)700470, Lot Number: 700470; UDI: (01)00880304673885(17)201015(10)722060, Lot Number: 722060; UDI: (01)00880304673885(17)230130(10)775330, Lot Number: 775330; UDI: (01)00880304673885(17)220620(10)858220, Lot Number: 858220; UDI: (01)00880304673885(17)211101(10)888080, Lot Number: 888080; UDI: (01)00880304673885(17)220221(10)992290, Lot Number: 992290

Distribution Pattern:

Worldwide distribution: US (nationwide) to states of: AR, CA, FL, GA, IL, IN, KS, MI, MN, MS, NC, OH, PA, TN, TX, and WV and country of: Canada.

Voluntary or Mandated:

Voluntary: Firm initiated